Evaluating Adult Patient Temperatures During Lower Spinal Surgery

Hypothermia Clinical Trial

Official title:

Comparing Patient Temperatures in Adults During Lower Spinal Surgery Using Either a Heated Ventilator Circuit or a Standard Ventilator Circuit With a Heat-Moisture Exchanger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050775
• Other study ID #: 15-001604
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: N/A
• Start date: August 28, 2015
• Est. completion date: February 5, 2017

Study information

• Verified date: May 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not. The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.

Description:

Patients were randomly assigned to either the treatment group or the control group prior to surgery. Prior to induction, patients in the control group were given inspiratory gas at ambient air temperature (20-22 degrees Celsius) and patients in the treatment group were given inspiratory gas at warmed temperatures (40-41 degrees Celsius). All patients were induced with general anesthesia in the supine position and repositioned prone following endotracheal intubation and placement of an esophageal stethoscope with a temperature sensor, as per usual hospital practice. Esophageal temperatures were recorded within 30 minutes of the baseline esophageal temperature and every 10 minutes thereafter for the first hour post-induction. All patients had a blanket and forced air warming applied to their lower extremities and upper back at 43 degrees Celsius after draping. All patients had esophageal temperature measurements recorded every 30 minutes until the patient was repositioned supine. Core temperatures were recorded four hours post-induction for those patients reaching that timeframe.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 5, 2017
• Est. primary completion date: February 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective spine surgery anticipated greater than three hours in duration

• Posterior approach

• An operative site between lumbar one and sacral one

• Involving two or more levels with fusion and/or instrumentation and/or revisions

• American Society of Anesthesiologists (ASA) Status of I-III

Exclusion Criteria:

• Patients with a tracheostomy

• Preoperative temperature >38°C or <36°C on the day of surgery

• Active infection or erythema to the back

• White blood cell count greater than 10,500/microliter (mcL)

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• Heated Ventilator Circuit
active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger
• Standard Ventilator Circuit
no active heat and humidification during anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Westmed, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Body Temperature	Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.	Approximately four hours post-induction of general anesthesia (or last recorded temperature)
Secondary	Intraoperative Core Temperatures Post-induction	Core body temperature will be taken in the esophagus after general anesthesia induction.	Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia
Secondary	Number of Subjects With Post-operative Shivering	Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis.	Approximately 2 hours after completion of the surgery
Secondary	Hospital Length of Stay	Number of days in the hospital	Surgery to hospital discharge
Secondary	Overall Post-operative Temperature	Temperature at Post Anesthesia Care Unit (PACU) arrival.	PACU arrival
Secondary	Number of Participants With Transfusion Within 48 Hours of Surgery	Requirement of blood transfusion within 48 hours of surgery	Within 48 hours of surgery
Secondary	Estimated Blood Loss	The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used.	duration of surgery